Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

Condition(s) targeted: Primary Immune Deficiency

Intervention: Immune Globulin Subcutaneous (Human) (SCIG) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Yoriyuki Shiga, Study Director, Affiliation: CSL Behring K.K.

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

Official title: A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: IgG Trough Level

Secondary outcome:

Number of Infection Episodes (Serious and Non-serious) by Study Period

Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population

Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population

Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period

Number of Days of Hospitalization Due to Infections by Study Period

Duration of Use of Antibiotics for Infection Prophylaxis and Treatment

Rate of All Adverse Events by Relatedness and Seriousness

Rate of Mild, Moderate, or Severe Local Reactions

Minimum age: N/A. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy

- Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for

at least 3 doses prior to signing of informed consent

- Written informed consent

Exclusion Criteria:

- Newly diagnosed PID, i. e., subjects who have not previously received immunoglobulin

replacement therapy

- Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia,

osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening

- Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic

leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma

- Allergic or other severe reactions to immunoglobulins or other blood products

recorded in the past 3 months or at the time of screening

- Pregnancy or nursing mother

- A positive result at screening on any of the following viral markers: human

immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus

- Participation in a study with other investigational product during this study and

within 3 months prior to screening

- Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior

to screening), or planning to donate blood during the study

Study site, Nagoya city, Aichi Pref. 466-8560, Japan

Study site, Chiba city, Chiba Pref. 260-8677, Japan

Study site, Gifu city, Gifu Pref. 501-1194, Japan

Study site, Sapporo city, Hokkaido 060-8648, Japan

Study site, Sendai city, Miyagi Pref. 980-8574, Japan

Study site, Fukuoka city, Osaka 812-8582, Japan

Study site, Moriguchi city, Osaka 570-8507, Japan

Study site, Osaka city, Osaka 534-0021, Japan

Study site, Koshigaya city, Saitama Pref. 343-8555, Japan

Study site, Tokorozawa city, Saitama Pref. 359-8513, Japan

Click here to request more information about this study

Related publications:

Igarashi A, Kanegane H, Kobayashi M, Miyawaki T, Tsutani K. Cost-minimization analysis of IgPro20, a subcutaneous immunoglobulin, in Japanese patients with primary immunodeficiency. Clin Ther. 2014 Nov 1;36(11):1616-24. doi: 10.1016/j.clinthera.2014.08.007. Epub 2014 Sep 16.

Starting date: September 2010
Last updated: November 25, 2014